Choosing the best countries and sites for your trial is critical to ensure patient recruitment goals are met, and that sites are able to comply with all aspects of the study protocol.
- Competitive Environment Analysis
- Patient population data anaysis
- Medical feasibility protocol assessment
- Country and site identification (long list and short lists)
- Feasibility questionnaire development
- Site outreach for formal feasibility assessments
Coordinating start up across multiple countries is challenging and often inefficient.
As requirements become more specialised the number of people involved can be huge. At Clinicology our very experienced clinical research professionals help streamline the interactions so that start up timelines are optimized.
Activities Include :
- Timeline planning and strategy
- Development of study documents (eg ICFs) and translations
- IRB/IEC Submission coordination on country and site level
- Site contract and budget negotiation
- Essential document collection
- Site activation “green light” document review to ensure ICH compliance